Clinical trial · Interventional
Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer
Phase I Study of Hypo-fractionated Neoadjuvant Radiotherapy for Locally Advanced Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Gastric cancer is one of the most common malignant tumors in China, and the incidence and mortality rate are second in malignant tumors. The treatment of gastric cancer need integrated multidisciplinary treatment, and surgery is the only possible curative method for gastric cancer at present. Previous studies have reported that neoadjuvant chemoradiotherapy can downstage primary tumor to increase radical resection rate in order to improve the long-term prognosis of advanced gastric cancer. However, there is no study on the application of hypo-radiotherapy to neoadjuvant radiotherapy in gastric cancer. The aim of this study was to observe the maximum tolerated dose (MTD) and dose limited toxicity (DLT) of hypo-fractionated radiotherapy for locally advanced gastric cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiation | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypo-fractionated radiotherapy | Radiation | — | UNRESOLVED |
| S1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypo-fractionated radiotherapy
- description
- Hypo-fractionated neoadjuvant radiotherapy concurrent with S1 chemotherapy for local advanced gastric cancer
- interventionNames
- Radiation: Hypo-fractionated radiotherapy
- Drug: S1
Primary outcomes (1)
- measure
- Maximum tolerated dose AND Dose limited toxicity
- timeFrame
- From date of enrollment until one month after chemo-radiotherapy
- description
- To assess maximum tolerated dose and dose limited toxicity of hypo-fractionated neoadjuvant radiotherapy
Secondary outcomes (2)
- measure
- Response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical stage T3-4N+M0 * Gastric cancer or Siewert II/III esophagogastric junction carcinoma; * Pathologically confirmed adenocarcinoma; * 18-75 years old, male or female; * Karnofsky score \>= 70; * White blood cell count \>= 4 x 109 / L; platelet count \>= 100 x109/L; serum creatinine =\< 1 x upper limit of normal, total bilirubin =\< 1 x upper limit of normal, alanine aminotransferase and aspartate aminotransferase =\< 2.5 x upper limit of normal, alkaline phosphatase =\< 5 x upper limit of normal. Exclusion Criteria: * Any chemotherapy or radiotherapy history before enrollment * Siewert I EGJ cancer
References
Publications (2)
- DERIVEDLi N, Xiang X, Zhao D, Wang X, Tang Y, Chi Y, Yang L, Jiang L, Jiang J, Shi J, Liu W, Fang H, Tang Y, Chen B, Lu N, Jing H, Qi S, Wang S, Liu Y, Song Y, Li Y, Zhang L, Jin J. Preoperative versus postoperative chemo-radiotherapy for locally advanced gastric cancer: a multicenter propensity score-matched analysis. BMC Cancer. 2022 Feb 26;22(1):212. doi: 10.1186/s12885-022-09297-7. PMID 35219300
- DERIVEDLi N, Wang X, Tang Y, Zhao D, Chi Y, Yang L, Jiang L, Jiang J, Liu W, Tang Y, Fang H, Liu Y, Song Y, Wang S, Jin J, Li Y. A prospective phase I study of hypo-fractionated neoadjuvant radiotherapy for locally advanced gastric cancer. BMC Cancer. 2018 Aug 8;18(1):803. doi: 10.1186/s12885-018-4707-9. PMID 30089457